n appropriate treatment.
Neutropenic infection: G3-4: 3.5%.
Not known:
Neutropenic sepsis.
Blood and lymphatic disorders
Very common:
Bone marrow depression resulting mainly in neutropenia G1-4: 71.5%; G3: 21.8%; G4: 25.9%, is reversible and is the dose limiting toxicity.
Leucopenia: G1-4: 70.6 %; G3: 24.7 %; G4: 6%.
Anaemia: G1-4: 67.4 %; G3-4: 3.8%.
Thrombocytopenia: G1-2: 10.8%.
Common:
G4 Neutropenia associated with fever over 38°C including febrile neutropenia 2.8%.
Metabolism and nutrition disorders
Not known:
Severe hyponatraemia.
Psychiatric disorders
Comon:
Insomnia : G1-2: 2.8%.
Nervous system disorders
Very common:
Neurosensory disorders: G1-2: 11.1%, generally limited to loss of tendon reflexes and infrequently severe.
Common:
Neuromotor disorders: G1-4: 9.2%; G3-4:1.3%.
Headache: G1-4: 4.1%, G3-4: 0.6%.
Dizziness: G1-4: 6%; G3-4: 0.6%.
Taste disorders: G1-2:3.8%.
Uncommon:
Ataxia grade 3: 0.3%.
Eye disorders
Common:
Visual disorders: G1-2: 1.3%.
Cardiac disorders
Not known:
Myocardial infarction in patients with cardiac medical history or cardiac risk factors.
Vascular disorders
Common:
Hypertension: G1-4: 2.5%; G3-4: 0.3%
Hypotension: G1-4: 2.2%; G3-4: 0.6%.
Respiratory system, thoracic and mediastinal disorders
Common:
Dyspnoea: G1-4: 2.8%; G3-4: 0.3%.
Cough: G1-2: 2.8%.
Gastrointestinal disorders
Very Common:
Nausea: G1-4: 74.7% ; G3-4: 7.3%;
Vomiting: G1-4: 54.7%; G 3-4: 6.3%, Supportive treatment such as 5HT3 antagonists (ondansetron) may reduce the occurrence of nausea and vomiting: see section 4.4.
Diarrhoea: G1-4: 49.7%; G3-4: 5.7%,
Anorexia: G 1-4: 38.6%; G 3-4: 4.1%,
Stomatitis: G1-4:10.4%; G3-4: 0.9%,
Abdominal pain: G1-4: 14.2%,
Constipation: G1-4: 19%; G3-4: 0.9%, Prescription of laxatives may be appropriate in patients with prior history of constipation and/or who receive concomitant treatment with opioid analgesics: see section 4.4.
Gastric disorders: G1-4: 11.7%.
Common:
Oesophagitis: G1-3: 3.8%; G3: 0.3%
Dysphagia: G1-2: 2.3%.
Uncommon:
Paralytic ileus: G3-4: 0.9% [rarely fatal], treatment may be resumed after recovery of normal bowel mobility.
Not known:
Gastro-intestinal bleeding.
Hepatobiliary disorders
Common:
Hepatic disorders: G1-2: 1.3%.
Skin and subcutaneous tissue disorders
Very common:
Alopecia usually mild in nature G1-2: 29.4%, may occur.
Common:
Skin reactions: G1-2: 5.7%.
Musculoskeletal and connective tissue disorders
Common:
Arthralgia including jaw pain, Myalgia: G1-4: 7 %, G3-4: 0.3%.
Renal and urinary disorders
Common:
Dysuria: G1-2: 1.6%.
Other genitourinary disorders: G1-2: 1.9%.
General disorders and administration site conditions
Very common:
Fatigue/malaise: G1-4: 36.7%; G3-4: 8.5%.
Feer: G1-4: 13.0%, G3-4: 12.1%.
Common:
Pain including pain at the tumour site: G1-4: 3.8%, G3-4: 0.6%.
Chills: G1-2: 3.8%.
Investigations
Ver common:
Weight loss: G1-4: 25%, G3-4: 0.3%.
Common:
Weight gain: G1-2: 1.3%.
Undesirable effects with Navelbine, concentrate for infusion:
Some undesirable effects |
